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Claims for Patent: 7,132,570

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Claims for Patent: 7,132,570

Title:Method for the production of crystalline forms and crystalline forms of optical enantiomers of modafinil
Abstract:The invention relates to a process for the preparation of crystalline forms of the optical enantiomers of modafinil, comprising stages comprising: i) dissolving one of the optical enantiomers of modafinil in a solvent other than ethanol, ii) crystallising the modafinil enantiomer, iii) recovering the crystalline form of the modafinil enantiomer so obtained. The invention also relates to a process for the preparation of the optical enantiomers of modafinil.
Inventor(s): Neckebrock; Olivier (Ponteau Combault, FR), Leproust; Pierre (Creteil, FR)
Assignee: Cephalon France (Maisons-Alfort Cedex, FR)
Application Number:10/539,918
Patent Claims: 1. A laevorotatory enantiomer of modafinil in a polymorphic form that produces a powder X-ray diffraction spectrum comprising intensity peaks at the interplanar spacings: 8.54, 4.27, 4.02, 3.98 (.ANG.).

2. The laevorotatory enantiomer of modafinil according to claim 1, wherein the polymorphic form produces a powder X-ray diffraction spectrum further comprising intensity peaks at the interplanar spacings: 13.40, 6.34, 5.01, 4.68, 4.62, 4.44, 4.20, 4.15, 3.90, 3.80, 3.43 (.ANG.).

3. A laevorotatory enantiomer of modafinil in a polymorphic form that produces a powder X-ray diffraction spectrum comprising reflections at 15.4, 31.1, 33.1 and 33.4 degrees 2.theta..

4. The laevorotatory enantiomer of modafinil according to claim 3, wherein the polymorphic form produces a powder X-ray diffraction spectrum further comprising reflections at 9.8, 20.8, 26.4, 28.3, 28.7, 29.9, 31.6, 32, 34.1, 35.1 and 39 degrees 2.theta..

5. A pharmaceutical composition comprising a laevorotatory enantiomer of modafinil according to any one of claims 1 to 4.

6. A pharmaceutical composition consisting essentially of a laevorotatory enantiomer of modafinil according to according to any one of claims 1 to 4.

7. A Form I polymorph of (-)-modafinil.

8. A pharmaceutical composition comprising a Form I polymorph of (-)-modafinil according to claim 7.

9. A pharmaceutical composition consisting essentially of a Form I polymorph of (-)-modafinil according to claim 7.

10. A process for preparing a Form I polymorph of (-)-modafinil comprising the steps of: (a) providing a solution of (-)-modafinil dissolved in a hot solvent; (b) rapidly cooling the solution from step (a) to produce crystals; (c) filtering the crystals; (d) drying the crystals; and (e) obtaining the crystals of said Form I polymorph of (-)-modafinil, wherein the solvent of step (a) is selected from water, methanol, absolute ethanol, absolute ethanol plus 3% water (v/v), and ethanol denatured with toluene plus 3% water, (v/v, based on the total volume of ethanol and toluene).
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